Group Head Biostatistics
vor 2 Wochen
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our ‘new’ Sandoz
**Your Key Responsibilities**:
Your responsibilities include, but not limited to:
- Ensure expert level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, negotiating with pricing agencies, influence and implement publication strategy, quantitative decision making) for critical studies in a program
Project level:
- Accountable for strategic statistical input and influence into one or more projects (development plan, dose-finding strategy, regulatory strategy, publication strategy, pricing & reimbursement strategy, statistical deliverables).
- May be a core member of GPT representing Biostatistics and Pharmacometrics.
- Lead collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making in drug development and enable successful impact on robust drug development plans.
- Collaborate cross-functionally (e.g. data management, statistical programming, medical writing) to ensure timeliness and quality of statistical deliverables.
- Facilitate seamless transition of projects from early to late development.
- Effective partnership with other functions to ensure integrated quantitative input into project.
- Propose and implement innovative designs and methods to optimize drug development.
- Plan, prioritize and oversee project level activities and ensure efficient resource management within or across franchise and effective partnership with vendors.
- Drive adherence to organizational standards and regulatory guidelines.
- Represent Biostatistics and Pharmacometrics line function at internal and external decision boards (e.g. regulators).
- Significantly contributes to project team preparation and may play a prominent role representing biostatistics at HA Advisory Committees and meetings.
Disease Area / TA/Indication level:
As partner to senior clinical and scientific leadership, drive strategic statistical input and excellence to drug development within the TA/DA/indications.Franchise or Global Line Function level:
- Lead or significantly contribute to initiatives at global line function level, or cross-functional franchise level, requiring coordination of diverse of team members.
- May contribute to line function review.
Enterprise level:
- Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives.
- Represent Biostatistics in due-diligence teams for low to mid-complexity in-licensing opportunities with mínimal supervision.
- Lead the review and implementation of health authority guidance.
- Identify, evaluate, and promote the use and the acceptance within and outside the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewed journals, presentations and chairing sessions at professional meetings.
External:
- Represent biostatistics in interacting with external experts (statistical, clinical, and technical).
- Chair sessions at professional meetings.
People Management:
- Develop and mentor statisticians.
- As global manager: responsible to recruit, retain and, professionally develop up to 10 biostatisticians.
**What you’ll bring to the role**:
Essential Requirements:
- MS or PhD in Biostatistik (or equivalent)
- MS (in Statistics or equivalent) with 12+ years relevant work experience or PhD (in Statistics or equivalent) with 8+ years relevant work experience.
- Influences decisions that directly impact the project and departments ability to deliver objectives
- Record of successful implementation of novel methods and/or innovative strategies in drug development
- Extensive knowledge of drug development and HA guidelines
- Strong understating of at least one disease area
- May have proven people leadership ability and expert skills in building partnerships and collaborations.
- Fluent English oral and written
- Excellent communication and presentation skills
- Good coaching and mentoring skills
- Good business ethics
**Why Sandoz?**
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and part